coding and reimbursement - iovera · the sciatic nerve can be treated to alleviate posterior knee...

This information is provided for general reference and informational purposes only. Each health care provider is ultimately responsible for determining the appropriate codes, coverage, and payment for individual patients. Pacira does not guarantee third-party coverage or payment for the iovera° treatment or reimburse for claims that are denied by third-party payers.

This information is provided for general reference and informational purposes only. Each health care provider is ultimately responsible for determining the appropriate codes, coverage, and payment for individual patients. Pacira does not guarantee third-party coverage or payment for the iovera° treatment or reimburse for claims that are denied by third-party payers.

Please see Important Safety Information on back cover.For more information, visit www.iovera.com.

iovera° CODING ANDREIMBURSEMENT

B I O S C I E N C E S , I N C .

iovera° and cryoanalgesia

System descriptionThe iovera° system is intended to treat peripheral nerves through the application of intense (extreme) cold via closed-end needles called “Smart Tips.” This treatment temporarily prevents the peripheral nerves from transmitting pain signals to the brain. This procedure is described as cryoanalgesia or cryoneurolysis.Since the temperature (-88° C) and duration (approximately 60-106 seconds) of individual treatment cycles are controlled by the iovera° system, the structural elements of the nerve bundle remain intact, allowing for complete regeneration and functional recovery of the nerve.1

Clinical valueCryoanalgesia has been used clinically for decades to provide temporary pain relief.2 A large body of clinical work and commercial use over the past 50 years demonstrates relief for patients with various types of pain. Because peripheral sensory nerve function is temporarily disrupted due to the destruction of the axon and myelin sheath, pain relief is provided until nerve regeneration occurs.

Ice ball for illustrative purposes.

Please see Important Safety Information on back cover.

Procedure and indication

The iovera° procedure (for treating superficial and deep genicular nerves)The iovera° system has a family of Smart Tips to treat anterior (superficial) and posterior (deep) genicular nerves. Smart Tip 309 provides safe and effective treatment of superficial nerves. Studies have shown that treating the anterior femoral cutaneous nerve (AFCN) and the infrapatellar saphenous nerve (ISN) can provide relief for anterior knee pain.3,4 It may also be necessary to treat the lateral femoral cutaneous nerve (LFCN). Smart Tip 190 offers a solution for treating deep genicular nerves. Two branches of the tibial nerve and the common peroneal nerve associated with the sciatic nerve can be treated to alleviate posterior knee pain.5-7

IndicationThe iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days.

The iovera° system is not indicated for treatment of central nervous system tissue. The iovera° system’s “1x90” Smart Tip configuration (indicating 1 needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator.

A

B

C

APC=ambulatory payment classification; ASC=ambulatory surgery center; CMS=Centers for Medicare and Medicaid Services; CPT=Current Procedural Terminology; HOPD=hospital outpatient department; ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification; RVU=relative value unit.

* Source: CMS, as of 2/1/2021. CMS 2021 (national average) final fee schedules. Subject to change based on CMS updates. CPT code selection is based on clinician determination.

Facility refers to HOPDs or ASCs, while non-facility refers to an office or a clinic that is not provider-based (eg, hospital)

Coding, coverage, and reimbursement considerations

Professional component*

CPT Code 64640 64624

Definition Destruction by neurolytic agent; other peripheral nerve or branch

Destruction by neurolytic agent; genicular nerve branches including imaging; destruction of each of the following genicular nerve branches: superolateral, superomedial, and inferomedial

ReimbursementThe diagnosis associated with the use of cryoneurolysis with iovera° may include knee pain (ICD-10-CM code M25.56X) or osteoarthritis of the knee (M17.X). The X is replaced with “1” to identify the left knee and “2” to identify the right knee.Anterior knee pain commonly involves the femoral nerve and most commonly the AFCN and 2 branches of the ISN. Other superficial nerves that innervate the knee such as the LFCN may also be involved. CPT code 64640 is applicable to iovera° treatments applied to peripheral nerves and is used to bill for EACH of the peripheral nerve or nerve branches treated.Posterior knee pain can involve the following deep genicular nerves: superolateral (superolateral articulating branch of the common peroneal nerve), superomedial (superomedial articulating branch of the tibial nerve), and inferomedial (inferomedial articulating branch of the tibial nerve). CPT 64624 defines all 3 of the specified nerves as 1 billable unit and is used for iovera° treatments of the referenced nerves. In the event that all 3 nerves are not treated, a modifier is to be used. Contact the Reimbursement Helpline for additional information.

It is the sole responsibility of the health care provider to correctly report all procedures and therapies. The following information is shared solely for informational and educational purposes.

Lateral femoralcutaneous nerveCAnterior femoral

cutaneous nerveA Infrapatellar branches of saphenous nerveB

When iovera° is utilized for anterior (superficial genicular) knee pain and total knee arthroplasty incision-related pain, CPT code 64640 can be used to indicate treatment of EACH of the following associated nerves:

CPT Code 64640 64624

Total Non-Facility RVUs 7.51 12.17

Work RVUs 1.98 2.50

Physician Fee Schedule (Non-Facility) $262.05 $424.65

Physician Fee Schedule (Facility) $120.73 $149.69

LFCN sensory zone

AFCN sensory zone

IBSN sensory zone


APC=ambulatory payment classification; ASC=ambulatory surgery center; CMS=Centers for Medicare and Medicaid Services; CPT=Current Procedural Terminology; HOPD=hospital outpatient department; ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification; RVU=relative value unit.

* Source: CMS, as of 2/1/2021. CMS 2021 (national average) final fee schedules. Subject to change based on CMS updates. CPT code selection is based on clinician determination.

Coding, coverage, and reimbursement considerations

CPT Code 64640 64624

Definition Destruction by neurolytic agent; other peripheral nerve or branch

Destruction by neurolytic agent; genicular nerve branches including imaging; destruction of each of the following genicular nerve branches: superolateral, superomedial, and inferomedial

AB

C

Facility componentFacility reimbursement*

CPT Code 64640 64624

APC#5443

Level III NerveInjections

#5431Level I Nerve

Procedure

HOPD Fee $822.46 $1754.39

ASC Fee $186.33 $804.72

Superolateral (superolateral articulating branch of the common peroneal nerve)

Superomedial (superomedial articulating branch of the tibial nerve)

Inferomedial (inferomedial articulating branch of the tibial nerve)

A

B

C

When iovera° is utilized for posterior (deep genicular) knee pain, CPT code 64624 can be used to indicate treatment of the following associated nerves:

Anatomical Orientation: Anterior View

In the past, the AMA has indicated that code 64999 (Unlisted procedure, nervous system) could be used for cryoneurolysis. Although 64999 may still be used to appropriately report factors related to a cryoneurolytic procedure, iovera° utilization should not be reported by using 64999. As with any coding submission, appropriate supporting evidence should be provided to ensure the correct code is being used

Multiple procedures and proper coding

Up to 5 nerves can be billed under 64640 but each nerve must be specified as a unique procedure. Later in this resource, sample scenarios are available for review (for illustrative purposes ONLY).

The proper reimbursement approach and amount will vary by payer

Reimbursement for treated nerves is as follows:

Nerve Treated First Second and Third Fourth and Fifth

Reimbursement Rate 100% 50% each 25% each

Considerations for cryoneurolysis of multiple nerves For reimbursement purposes, the treatment of multiple nerves is considered as multiple procedures. Although the treatment protocol is often performed during a single visit, each superficial nerve treated for anterior knee pain using 64640 is considered an individual procedure. As an example, if the AFCN and the 2 branches of the ISN are treated, it is defined as 3 procedures. When more than 1 procedure is performed, the multiple procedure rule applies and results in different reimbursement rates for each procedure.

AMA=American Medical Association.


The proper reimbursement approach and amount will vary by payer

Reimbursement for treated nerves is as follows: The codes below should not be used to specify the use of iovera°

0440T Ablation, percutaneous, cryoablation, includes imaging guidance; upper extremity distal/peripheral nerve

0441T Lower extremity distal/peripheral nerve

0442T Nerve plexus or other truncal nerve (eg, brachial plexus, pudendal nerve)

Incompatible coding for iovera°A number of codes, specifically category III codes 0440T through 0442T, address a similar but distinct procedure. They refer to cryoablation, and not cryoneurolysis.

Further guidance and support

Individuals with current access to the AMA CPT Assistant can always cross reference the latest available guidance on coding protocols

The information in this resource is provided for general reference and informational purposes only. Each health care provider is ultimately responsible for determining the appropriate codes, coverage, and payment for individual patients. Pacira does not guarantee third-party coverage or payment for the iovera° treatment or reimburse for claims that are denied by third-party payers.

ASC

FACILITY COMPONENTNATIONAL

PHYSICIAN COMPONENTNATIONAL

3 PERIPHERAL NERVES TREATMENT* - WITH ULTRASOUND

76942 - Ultrasound Guidance N/A(Considered packaged in ASC) $31.40

64640 $186.33 $120.7364640 (50% of rate because considered a second procedure) $93.17 $60.37

100% $186.33 $120.7364640 (50% of rate because considered a third procedure) $93.17 $60.37

100% $186.33 $120.73TOTAL $372.67 $272.87

DEEP GENICULAR TREATMENT ONLY†

64624 $804.72 $149.69TOTAL $804.72 $149.69

DEEP GENICULAR AND SINGLE PERIPHERAL (ANTERIOR) NERVE TREATMENT‡ (NO ULTRASOUND FOR ANTERIOR)


100% $186.33 $120.73TOTAL $897.89 $210.06

DEEP GENICULAR AND SINGLE PERIPHERAL (ANTERIOR) NERVE TREATMENT‡ (NO ULTRASOUND FOR ANTERIOR)



100% $186.33 $120.7364640 (25% of rate because considered a fourth procedure) $46.58 $30.18

100% $186.33 $120.73TOTAL $1037.64 $300.61

DEEP GENICULAR AND SINGLE PERIPHERAL (ANTERIOR) NERVE TREATMENT‡ (WITH ULTRASOUND FOR ANTERIOR)

64624 $804.72 $149.69

76942 - Ultrasound Guidance N/A(Considered packaged in ASC) $31.40

64640 (50% of rate because considered a second procedure) $90.10 $60.37100% $186.33 $120.73

64640 (50% of rate because considered a third procedure) $93.17 $60.37100% $186.33 $120.73

64640 (25% of rate because considered a fourth procedure) $46.58 $30.18100% $186.33 $120.73

TOTAL $1034.57 $332.01

*AFCN and 2 branches of the ISBN.†Superolateral, superomedial, and inferomedial nerves.‡Superolateral, superomedial, and inferomedial nerves and AFCN.

Sample scenarios: ASC


HOPD

FACILITY COMPONENTNATIONAL

PHYSICIAN COMPONENTNATIONAL


76942 - Ultrasound Guidance N/A(Considered packaged in HOPD) $31.40

64640 $822.46 $120.73 64640 (50% of rate because considered a second procedure) $411.23 $60.37

100% $822.46 $120.73 64640 (50% of rate because considered a third procedure) $411.23 $60.37

100% $822.46 $120.73 TOTAL $1644.92 $272.87


64624 $1754.39 $149.69 TOTAL $1754.39 $149.69

DEEP GENICULAR AND SINGLE PERIPHERAL (ANTERIOR) NERVE TREATMENT (NO ULTRASOUND FOR ANTERIOR)‡


100% $822.46 $120.73TOTAL $2165.62 $210.06




100% $822.46 $120.7364640 (25% of rate because considered a fourth procedure) $205.62 $30.18

100% $822.46 $120.73TOTAL $2782.47 $300.61

DEEP GENICULAR AND SINGLE PERIPHERAL (ANTERIOR) NERVE TREATMENT (WITH ULTRASOUND FOR ANTERIOR)‡

64624 $1754.39 $149.69

76942 - Ultrasound Guidance N/A(Considered packaged in HOPD) $31.40

64640 (50% of rate because considered a second procedure) $411.23 $60.37100% $822.46 $120.73

64640 (50% of rate because considered a third procedure) $411.23 $60.37100% $822.46 $120.73

64640 (25% of rate because considered a fourth procedure) $205.62 $30.18100% $822.46 $120.73

TOTAL $2782.47 $332.01

Sample scenarios: HOPD

PHYSICIAN OFFICE

PHYSICIAN COMPONENT ONLYNATIONAL


76942 - Ultrasound Guidance $58.97

64640 $262.05

64640 (50% of rate because considered a second procedure) $131.03

100% $262.0564640 (50% of rate because considered a third procedure) $131.03

100% $262.05TOTAL $583.08


64624 $424.65

TOTAL $424.65


64624 $424.65


100% $262.05TOTAL $555.68


64624 $424.65



100% $262.0564640 (25% of rate because considered a fourth procedure) $65.51

100% $262.05TOTAL $752.22

DEEP GENICULAR AND SINGLE PERIPHERAL (ANTERIOR) NERVE TREATMENT (WITH ULTRASOUND FOR ANTERIOR)‡

64624 $424.65

76942 - Ultrasound Guidance $58.97



100% $262.0564640 (25% of rate because considered a fourth procedure) $65.51

100% $262.05

TOTAL $811.19


Sample scenarios: Physician office

*AFCN and 2 branches of the ISBN.†Superolateral, superomedial, and inferomedial nerves.‡Superolateral, superomedial, and inferomedial nerves and AFCN.

You can contact a dedicated reimbursement specialist:1-855-793-9727 [email protected]

Reimbursement and support

Do you have questions about coding and reimbursement? Our dedicated team of reimbursement experts are available to ensure you have all

required information or documentation about:

CPT billing codes and modifiers

Medical necessity

Medicare and commercial

reimbursement

We can support your team’s planning process when adopting the use of iovera° and address any reimbursement needs that arise. Please feel free to

contact the helpline even before iovera° is used, so that questions or potential reimbursement issues can be addressed ahead of time.

Important safety information

B I O S C I E N C E S , I N C .

ContraindicationsThe iovera° system is contraindicated for use in patients with the following:• Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud’s disease, and open and/or

infected wounds at or near the treatment site

Potential complicationsAs with any surgical treatment that uses needle-based therapy and local anesthesia, there is a potential for site-specific reactions, including, but not limited to:• Ecchymosis, edema, erythema, local pain and/or tenderness, and localized dysesthesiaProper use of the device as described in the User Guide can help reduce or prevent the following complications: • At the treatment site(s): injury to the skin related to application of cold or heat, hyper- or

hypopigmentation, and skin dimpling• Outside the treatment site(s): loss of motor function

References: 1. Hsu M, Stevenson FF. Reduction in muscular motility by selective focused cold therapy: a preclinical study. J Neural Transm (Vienna). 2014;121(1):15-20. 2. Ilfeld BM, Preciado J, Trescot AM. Novel cryoneurolysis device for the treatment of sensory and motor peripheral nerves. Expert Rev Med Devices. 2016;13(8):713-725. 3. Radnovich R, Scott D, Patel AT, et al. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017;25(8):1247-1256. 4. Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016;23(3):523-528. 5. Davis T, Loudermilk E, DePalma M, et al. Prospective, multicenter, randomized, crossover clinical trial comparing the safety and effectiveness of cooled radiofrequency ablation with corticosteroid injection in the management of knee pain from osteoarthritis. Reg Anesth Pain Med. 2018;43(1):84-91. 6. Davis T, Loudermilk E, DePalma M, et al. Twelve-month analgesia and rescue, by cooled radiofrequency ablation treatment of osteoarthritic knee pain: results from a prospective, multicenter, randomized, cross-over trial. Reg Anesth Pain Med. 2019;44(4):499-506. 7. Walega D, McCormick Z, Manning D, Avram M. Radiofrequency ablation of genicular nerves prior to total knee replacement has no effect on postoperative pain outcomes: a prospective randomized sham-controlled trial with 6-month follow-up. Reg Anesth Pain Med. 2019;44(6):646-651.

©2021 Pacira BioSciences, Inc. All rights reserved. iovera° is a trademark of Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc. PP-IO-US-0483 02/21

coding and reimbursement - iovera · the sciatic nerve can be treated to alleviate posterior knee...

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